Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

PHASE3TerminatedINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

June 8, 2020

Primary Completion Date

October 2, 2024

Study Completion Date

October 2, 2024

Conditions
Myelodysplastic SyndromesLeukemia, Myelomonocytic, Chronic
Interventions
DRUG

Sabatolimab

A dose of MBG453 800 mg will be administered intravenously (IV) every 4 weeks (Q4W).

DRUG

Azacitidine

A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9.

DRUG

Placebo

A dose of Placebo 800 mg will be administered intravenously every 4 weeks (Q4W).

Trial Locations (149)

123

Novartis Investigative Site, Muscat

970

Novartis Investigative Site, Hualien City

2930

Novartis Investigative Site, Brasschaat

3010

Novartis Investigative Site, Bern

3168

Novartis Investigative Site, Clayton

4020

Novartis Investigative Site, Linz

4102

Novartis Investigative Site, Wooloongabba

6000

Novartis Investigative Site, Perth

6020

Novartis Investigative Site, Innsbruck

8036

Novartis Investigative Site, Graz

8091

Novartis Investigative Site, Zurich

8800

Novartis Investigative Site, Roeselare

10002

Novartis Investigative Site, Taipei

10021

Weill Cornell Medicine NY-Presb, New York

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

10990

Novartis Investigative Site, Pulau Pinang

11211

Novartis Investigative Site, Riyadh

12808

Novartis Investigative Site, Prague

14642

University of Rochester Medical Ctr, Rochester

16132

Novartis Investigative Site, Genova

17475

Novartis Investigative Site, Greifswald

20089

Novartis Investigative Site, Rozzano

20162

Novartis Investigative Site, Milan

22030

Novartis Investigative Site, Edirne

22903

University of Virginia, Charlottesville

24116

Novartis Investigative Site, Kiel

28009

Novartis Investigative Site, Madrid

31059

Novartis Investigative Site, Toulouse

32224

Mayo Clinic Jacksonville, Jacksonville

33011

Novartis Investigative Site, Oviedo

33136

University Of Miami, Miami

33305

Novartis Investigative Site, Taoyuan District

34899

Novartis Investigative Site, Pendik Istanbul

35100

Novartis Investigative Site, Izmir

37007

Novartis Investigative Site, Salamanca

37044

Novartis Investigative Site, Tours

38043

Novartis Investigative Site, Grenoble

40002

Novartis Investigative Site, Khon Kaen

40138

Novartis Investigative Site, Bologna

40447

Novartis Investigative Site, Taichung

40479

Novartis Investigative Site, Düsseldorf

41013

Novartis Investigative Site, Seville

42551

Novartis Investigative Site, Velbert

46010

Novartis Investigative Site, Valencia

46026

Novartis Investigative Site, Valencia

50134

Novartis Investigative Site, Florence

50200

Novartis Investigative Site, Chiang Mai

52787

Novartis Investigative Site, Estado de México

53100

Novartis Investigative Site, Satélite

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

55139

Novartis Investigative Site, Samsun

58260

Novartis Investigative Site, Morelia

59037

Novartis Investigative Site, Lille

59100

Novartis Investigative Site, Kuala Lumpur

60590

Novartis Investigative Site, Frankfurt am Main

60611

Northwestern University, Chicago

68000

Novartis Investigative Site, Kuala Selangor

70211

Novartis Investigative Site, Kuopio

75475

Novartis Investigative Site, Paris

83301

Novartis Investigative Site, Kaohsiung City

85364

Yuma Regional Cancer Center, Yuma

86179

Novartis Investigative Site, Augsburg

89081

Novartis Investigative Site, Ulm

89100

Novartis Investigative Site, Reggio Calabria

90095

University of California LA, Los Angeles

90110

Novartis Investigative Site, Songkhla

93586

Novartis Investigative Site, Kuching

95123

Novartis Investigative Site, Catania

100029

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

110231

Novartis Investigative Site, Bogotá

119074

Novartis Investigative Site, Singapore

130021

Novartis Investigative Site, Changchun

169608

Novartis Investigative Site, Singapore

191024

Novartis Investigative Site, Saint Petersburg

197022

Novartis Investigative Site, Saint Petersburg

200025

Novartis Investigative Site, Shanghai

200233

Novartis Investigative Site, Shanghai

215004

Novartis Investigative Site, Suzhou

250012

Novartis Investigative Site, Jinan

300020

Novartis Investigative Site, Tianjin

300052

Novartis Investigative Site, Tianjin

310003

Novartis Investigative Site, Hangzhou

380009

Novartis Investigative Site, Ahmedabad

430022

Novartis Investigative Site, Wuhan

430030

Novartis Investigative Site, Wuhan

510080

Novartis Investigative Site, Guangzhou

510515

Novartis Investigative Site, Guangzhou

518037

Novartis Investigative Site, Shenzhen

610041

Novartis Investigative Site, Chengdu

625107

Novartis Investigative Site, Madurai

700014

Novartis Investigative Site, Kolkata

700160

Novartis Investigative Site, Kolkata

736005

Novartis Investigative Site, Liouying Township

1834111

Novartis Investigative Site, Afula

2540364

Novartis Investigative Site, Viña del Mar

6423906

Novartis Investigative Site, Tel Aviv

06520

Yale University School Of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

07601

Hackensack University Medical Ctr, Hackensack

B1629AHJ

Novartis Investigative Site, Pilar

88034-000

Novartis Investigative Site, Florianópolis

04014-002

Novartis Investigative Site, São Paulo

05319-000

Novartis Investigative Site, São Paulo

T2N 4N2

Novartis Investigative Site, Calgary

M4N 3M5

Novartis Investigative Site, Toronto

054047

Novartis Investigative Site, Rionegro

128 20

Novartis Investigative Site, Prague

500 05

Novartis Investigative Site, Hradec Králové

625 00

Novartis Investigative Site, Brno Bohunice

FIN 00290

Novartis Investigative Site, Helsinki

01307

Novartis Investigative Site, Dresden

07740

Novartis Investigative Site, Jena

681 00

Novartis Investigative Site, Alexandroupoli

265 00

Novartis Investigative Site, Pátrai

121 001

Novartis Investigative Site, Faridabad

110 085

Novartis Investigative Site, Delhi

00133

Novartis Investigative Site, Roma

464 8681

Novartis Investigative Site, Nagoya

277 8577

Novartis Investigative Site, Kashiwa

812-8582

Novartis Investigative Site, Fukuoka

064 0804

Novartis Investigative Site, Sapporo

259-1193

Novartis Investigative Site, Isehara

980 8574

Novartis Investigative Site, Sendai

852-8501

Novartis Investigative Site, Nagasaki

589 8511

Novartis Investigative Site, Ōsaka-sayama

113-8603

Novartis Investigative Site, Bunkyo-ku

545-8586

Novartis Investigative Site, Osaka

990 9585

Novartis Investigative Site, Yamagata

1107 2020

Novartis Investigative Site, Beirut

LT-08661

Novartis Investigative Site, Vilnius

06726

Novartis Investigative Site, Mexico City

9713 GZ

Novartis Investigative Site, Groningen

1099 023

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

06591

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08916

Novartis Investigative Site, Badalona

08035

Novartis Investigative Site, Barcelona

06230

Novartis Investigative Site, Ankara

PO6 3LY

Novartis Investigative Site, Portsmouth

EH4 2XU

Novartis Investigative Site, Edinburgh

M20 2BX

Novartis Investigative Site, Manchester

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY